Clinical Trials Directory

Trials / Completed

CompletedNCT03707184

Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
17 (actual)
Sponsor
University of Utah · Academic / Other
Sex
Male
Age
—
Healthy volunteers
Not accepted

Summary

This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. Abnormal fluciclovine F18 (\[18F\] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed). II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed). SECONDARY OBJECTIVES: I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure. II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline. III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment. OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone). Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. After completion of diagnostic testing, patients are followed for 2 years.

Conditions

Interventions

TypeNameDescription
PROCEDUREComputed TomographyUndergo PET/CT scan
DRUGFluciclovine F18Given IV
PROCEDUREPositron Emission TomographyUndergo PET/CT scan

Timeline

Start date
2018-10-02
Primary completion
2022-02-03
Completion
2022-02-03
First posted
2018-10-16
Last updated
2024-11-29
Results posted
2024-11-29

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03707184. Inclusion in this directory is not an endorsement.